Trial Outcomes & Findings for Motorized Continuous Cold Therapy Versus Standard Post-op Icing Protocol for Two Foot and Ankle Procedures (NCT NCT00950183)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

36 participants

Primary outcome timeframe

postop day 1 up to postop day 14

Results posted on

2016-08-22

Participant Flow

The study was terminated before patients were randomized to the treatment arms. Thus, it is not possible to report the results for the individual treatment arms.

Participant milestones

Participant milestones
Measure	Foot and Ankle Surgery
Overall Study STARTED	36
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	36

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Motorized Continuous Cold Therapy Versus Standard Post-op Icing Protocol for Two Foot and Ankle Procedures

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Foot and Ankle Surgery n=36 Participants Our target enrollment was 82 participants. We only enrolled 36 participants. The study was terminated due to low enrollment. As a result, patients were never randomized.
Age, Continuous	56 Years n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: postop day 1 up to postop day 14

Population: Data not analyzed due to study termination

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: postop day 1 up to postop day 14

Population: Data not analyzed due to study termination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: first postoperative visit (between postop day 10 and 14)

Population: Data not analyzed due to study termination

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day of Surgery

Population: Data not analyzed due to study termination

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: postop day 1 up to postop day 14

Population: Data not analyzed due to study termination

Outcome measures

Outcome data not reported

Adverse Events

Foot and Ankle Surgery

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Robert B. Anderonson

OrthoCarolina

Phone: 704-323-2000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place